natgillin/translations-raw huggingface dataset:
Most ILCs and PT schemes involve comparison of participants results withan assigned value, which has been delivered by a reference laboratory, a sub-groupof participants, consensus from the overall population of test results or by some othermeans.
Majoritatea schemelor ILC şi PT implic comparri ale rezultatelor participan ilor cu o valoare atribuita anterior, care a fost declarat de un laborator de referin , sau de un subgrup de participan i, sau ca valoare de consens pe baza rezultatelor participan ilor sau, ca valoare care a fost atribuit prin alte mijloace.
Corrective actions after participation to ILCs are also briefly discussed.
Se discut de asemenea, pe scurt, ac iunile corective care trebuie sa se ia dup participarea la ILC-uri.
Past and next future of TrainMiC
Trecutul şi viitorul TrainMiC
The workshop “Improving the Scientific Base for Metrology in Chemistry (MIC)in EU Accession Countries” organised in February 2001 by the IRMM, initiatedthe TrainMiC concept.
Workshop-ul cu tema "Îmbunt irea bazei ştiin ifice pentru Metrologie în Chimie (MiC) în rile candidate la integrarea în UE" organizat de IRMM, Geel, Belgia în februarie 2001 a ini iat conceptul TrainMiC.
Renowned speakers representing establishedorganisations in the field of metrology in chemistry gave plenary presentations.Several working group discussions followed [J.V. Norgaard, I. Papadakis, P.
Cu aceast ocazie, câ iva renumi i lectori, reprezentând organiza ii din domeniul metrologiei în chimie au inut diverse prezentri. Au urmat apoi discu ii în cadrul grupelor de lucru [J.V.Norgaard, I. Papadakis, P. Taylor Accred. Qual Assurance 6 (2001) 443].
Accession/Candidates Countryrepresentatives from the academia, accreditation bodies and metrologyinstitutes expressed their needs and expectations in the field of MiC.
Reprezentan i din câteva ri candidate, care au reprezentat universit i, organisme de acreditare şi institute de metrologie şi-au exprimat problemele şi preocuprile lor în domeniul MiC.
One of the conclusions was the need to improve the knowledge transfer of the basic MiC concepts - already implemented in the ISO/IEC 17025 - to the laboratorypractitioners.
Una dintre concluzii a fost necesitatea de transfer de cunoştin e privind conceptele de baz ale MiC, - concepte deja implementate în ISO/IEC 17025 – pentru practicienii din laboratoare.
The following key words were frequently cited: measurementuncertainty, traceability of a measurement result, validation of measurementprocedure and the proper use of certified reference materials.
Au fost citate frecvent urmtoarele expresii cheie: incertitudine de msurare, trasabilitate a rezultatului msurrii, validarea procedurii de msurare şi folosirea corect a materialelor de referin certificate.
The differentingredients of the TrainMiC curricula were defined.
In cadrul acestui workshop, au fost definite câteva subiecte privind con inutul TrainMiC.
The first TrainMiC event was held in September 2001 at Sinaia, Romania.Several speakers from different organisations were invited to lecture on theabove topics.
Primul seminar TrainMiC sa inut în Septembrie 2001 la Sinaia, România. Au fost invita i câ iva lectori din partea mai multor organiza ii, care s prezinte subiectele de mai sus.
This interdisciplinary course was appreciated and well perceivedby the participants, thus confirming the expectations expressed earlier in Geel.The next task was to prepare a structured and coherent training material to besystematically presented and distributed to participants.
Acest curs interdisciplinar a fost bine apreciat şi perceput de participan i, confirmându-se astfel dezbaterile anterioare de la Geel. Urmtoarea sarcin a fost de a pregti un material de instruire, structurat şi coerent, care s fie prezentat sistematic şi distribuit participan ilor.
Two brainstorming retreats of several authors in Dendermonde and Mechelen(Belgium) resulted in a set of “TrainMiC” slides that were used throughout thedifferent 2002 courses and constantly refined.
Ca urmare a dou întruniri de lucru cu diverşi autori ai acestui raport, întruniri care au avut loc la Dendermonde şi Mechelen (Belgia) a rezultat un set de documente "TrainMiC" care au fost folosite la diferitele cursuri inute în 2002, documente care apoi au fost revizuite periodic.
The first standardised version of the TrainMiC book was presented at the Warsaw event in November 2002.
Prima versiune standardizat a manualului TrainMiC a fost prezentat la seminarul de la Varşovia, în noiembrie 2002.
The “traceability” and “validation” moduleswere not included, as they required further refinement.
Modulele "trasabilitate" şi "validare" nu au fost incluse pentru c se cerea în continuare îmbunt irea lor.
The complete course material was provided to the European Accreditation(EA) technical assessors in May 2003, and to Bulgarian participants in June2003.
Materialul complet al cursului a fost oferit evaluatorilor tehnici din cadrul organiza iei Europene de Acreditare (EA) în mai 2003 şi participan ilor bulgari, în iunie 2003.
The final version of seven modules is presented in the Appendix.
Versiunea final a celor şapte module este prezentat în anex.
Till August 2003, seventeen TrainMiC events were organised in eightcountries, thus reaching 794 participants from many different analyticalsectors.
Pân în august 2003 sau organizat 17 seminarii TrainMiC în 8 ri, la acestea participând 794 de persoane din sectoare analitice diferite.
The final objective is to arrange two courses per year per country,thus resulting in approximately 20 events per year.
Obiectivul final al programului TrainMiC este organizarea a 2 cursuri pe an în fiecare ar, conducând astfel la circa 20 de seminarii anual.
Such an ambitious program requires the recruitment of additional trainers.National trainers were selected to palliate for any language problems duringthe lectures.
Un program aşa de ambi ios necesit recrutarea de instructori suplimentari. De aceea, au fost selecta i instructorii na ionali, evitându-se astfel şi orice problem de limbaj pe durata instruirilor.
When necessary, the modules included in this report will betranslated in various languages.
Dac se va considera necesar, modulele incluse în acest raport pot fi traduse în diverse limbi.
The Polish, Bulgarian and Romanianversions are being prepared.
Versiunile în polon, bulgar şi român au fost deja pregtite.
TrainMiC courses in local (non-English)languages will be available in 2004.
Cursurile TrainMiC în limbile locale (altele decât engleza) vor fi disponibile în 2004.
While TrainMiC is successfully propagating in the new acceding countries,new modules are under development, i.e. one about “sampling” and one onthe “interpretation of reported uncertainty”.
Deoarece programul TrainMiC se propag cu succes în noile ri ce acced la integrarea în UE, se pregtesc noi module, de ex. unul privind "eşantionarea" şi altul despre "interpretarea incertitudinii raportate".
TrainMiC events remaining for 2003
Seminarii TrainMiC rmase pentru anul 2003
Introduction to Metrology in Chemistry building a metrologicalysound infrastructurefor chemical measurements
Introducereîn Metrologieîn Chimie
This course is for people ...
Acestcurs estededicatspecialiştilor...
Performing measurements that–Are crossing borders between laboratories
•Caredesfşoarmsurri–cesunt folosite înafaralaboratoruluipropriu
–Are crossing national borders (e.g. trade)–Will be used in a legislation context
–ce sunt folosite înafaragrani elorunei ri
(e.g. control lab, enforcement agency)
(ex. comertul)
Overview
Con inutulcursului
– What is Metrology in Chemistry ?
– Ce este Metrologia în Chimie ?
– Why is it needed ?
–De ceesteea necesar?
– What are the differences with Metrology in Physics ?
–Care suntdiferen elefa de Metrologia în Fizic ?
Define a common language
•Aratimportan a acesteia
Quality of measurement results
• Calitatea rezultatelor m sur rilor
The new Global Approach of CIPM-MRA: focus on metrology & on integration Slide 3
Noua Abordare Global a CIMP-MRA: accent pemetrologie & integrare Slide 3
Is about understanding the measurement procedure
Metrologia= Stiin & aM sur rilor Se ocupcuîntelegereaprocesuluide msurare
Modern societies use measurements
Societ ilemodernefolosescmsurrile
• in technology• in trade• when making regulations(about 40% EU directives involve measurements)
•întehnologie•încomer •cândse facreglementri(circa 40% din directivele
Metrology is important and the EC supports it!
Metrologia este important şi CE o sprijin!
Approach in Analytical Chemistry
Abordarea în Chimia Analitic
Some principles :
Uneleprincipii:
•remain the same ...•some are improved !•some are changed !
•rmân aceleaşi...•suntîmbunt ite!•se schimb!
My result is correct, but I don’t need to show why it is not necessary to state & demonstrate traceability It is not possible to write model equation
& demonstrez / Nu este necesar trasabilitatea
It is not possible to use a common approach foruncertainty estimation
/Nuesteposibilsse foloseasco abordarecomunpentruestimareaincertitudinii
The smaller the number behind “ ± ”the better my laboratory
/Cu cât e maimicnumrulcare urmeazdup“ ± ” cu atât e maibun laboratorulmeu
I did this for long time and I know my business
/Factreabaaceastade multtimpşiîmi cunoscmeseria
Limited information: ‘the Truth’ only exists theoretically,as it can only be approximated
•Informa iaestelimitat: ‘Adevrul’ estenumaiteoretic, aşa cpoatefidoaraproximat
•Critical review: there are never problems,unless you look critically
•Tratarecritic: nuexistniciodatprobleme, decât dacpriveşticritic
What are you trying to measure?What is your measurand?
Ceîncerca i smsura i?Care estemsuranduldvs.?
XXI cent.
Biochimic secolul XXI .
Laboratory provides results to Customer/Client
Laboratorul ofer rezultate clientului
Result = value ± uncertainty
Rezultat= valoare± incertitudine exprim încrederea intrinsec în
Uncertainty expresses intrinsic reliability of the result
• Incertitudinea rezultat
ISO-GUM Common way of estimating uncertainty
•ISO-GUM �modalitateacomunpentruestimareaincertitudinii
Avoid sector-specific terms (such as precision’, in-between-method precision, etc …)
•Se evittermeniispecificidinfiecaresector (precum‘preciziaintermediar’, repetabilitatea, reproductibilitateametodeietc...)
State, establish and demonstratetraceability
9Declararea, stabilireaşidemonstrareatrasabilit ii
Tracing measurements to somelocal measurement standard issufficient
�Trasabilitateamsurrilorla uneleetaloanelocale estesuficient
Every sector decides on how toexpress reliability
9 Incertitudinea GUM �o abordarestandardizatîntrediferitedomenii
GUM uncertainty standardisedapproach across sectors
�Fiecaresector de activitatedecide cum sexprimeîncredereaînrezultatelelor
Repeating measurements givesall the needed information
9 Increderea m sur rilor nu cre ş te numai prin repetarea lor
Is related to the fundamentals of analytical chemistry
Esteînlegaturcu fundamentelechimieianalitice
Is needed to obtain good quality measurement results
Estenecesarsse obtinrezultateale msurrilorde bun calitate
Is the responsibility of every laboratory performing the measurement
Esteresponsabilitateafiecruilaboratorcare efectueaz m sur ri
MiC : various factors affect the quality of results strongly “sample-dependent”
MiC : numeroşi factoriafecteazcalitatearezultatelor�msurareaestestrâns “dependentde prob”
Concentration of Cd in.. sea water soils blood infant food
Concentra iade Cdîn..9apde mare9sol9sânge9hranasugarului
Metrology in Physics v.s. Chemistry
Metrologiaîn Fizic fat de Metrologia în Chimie
Major Impact: (equipment) calibration
Impact Major : etalonarea(echipamentului)
MiC : Chemical Measurement =comparing a quantity of analyte (e.g.
MiC : Msurarechimic= comparareauneicantit i de analit
Major impact:sampling, DDT extraction, calibration solutions,matrix digestion, and… (equipment) calibration
Impact Major : eşantionare, extrac ia DDT , solu iilede etalonare, digestiamatricei, şi… etalonareaechipamentului
‘Analyte’ : the compound, species you measure
‘Analit’: compusul, speciilede msurat
‘Model’ : the equation you use to calculate your final result(you always use one!).
‘Model matematic’: ecua iafolositpentrucalcululrezultatuluifinal (întotdeaunase folosesteunmodel!).
This model is an (approximating) description of reality
Acestmodel esteo descriere(prinaproximare)a realit ii
SI w(Pb) in waste water m-2
SI w(Pb) înaprezidual m-2
Count
Nu mr
SI number of E.Coli/surface
SI numr de E.Coli/suprafa
+ ions pH
SI ioni H+ pH unitatede pH
A measurement in chemistry involves ...
Msurareaîn chimiepresupune...
Result Reporting: value ± uncertainty
;Reportarearezultatelor: valoare±incertitudine
Quality of chemicalmeasurement results today
Calitateaactuala rezultatelormsurrilor
A claim is not a demonstrated proof !
0Declara ianue o dovaddemonstrat!
• if you use written standards, you automatically get betterquality results …
•dacfolositistandardescrise, ob ine i automat rezultatede calitatesuperioar…
• if you use a CRM, you automatically get better qualityresults …
•dacfolosi i un MRC, ob ine i automatrezultatede calitatesuperioar…
Lead concentration in Wine (IMEP-16)
Concentra iade Pb în vin (IMEP-16)
EC Directive 2001/22EC Regulation 2676/90EC Regulation 466/2001 threshold value of 0.2 mg Pb /Kg
Directiva EC 2001/22 Reglementarea EC 2676/90 Reglementarea EC 466/2001 �valoareaadmis0.2 mg Pb/Kg
With – W/O Quality System µg
Cu – Fr Sistem al Calit ii µg
Depends on analytical technique used?
Depindede tehnicaanaliticutilizat?
With – W/O Official/written standard
Cu –Farstandardeoficiale
Some better concepts ...
Unele concepte mai bune...
There are some basic things which apply to anymeasurement (also chemistry)
•Existunelelucrurifundamentalecare se aplicla oricemsurare(inclusivînchimie)
This has a consequence on how measurement scientists‘organise themselves’ (preferably NOT on a sector-by-sector level)
•Aceastaare dreptconsecin modulîncare specialiştiiînmsurrise ‘organizeaz(de preferin NU numaila nivelde sector)
A laboratory also needs to get ‘its act together’ as anorganisation
•Un laboratortrebuie, deasemenea, s‘func ioneze’ ca o organiza ie
•Nothing beats experimental proof to substantiate a claim
•Nimicnuconfermaimultîncredereuneideclara ii decât o dovadexperimental
Validated procedures
• Instruirea/expertizarea personalului
Document control
• Folosirea MRC-urilor
Records control
• Controlul documentelor
Uncertainty budget
•Bugetde incertitudini
Instrument reception
• Controlul înregistr rilor
Traceability of results
• Trasabilitatea rezultatelor
TrainMiC the Metrology ‘Cooking Art’
‘Arta’ Metrologiei
Choose correct measurement systemtake a validated procedure and demonstrate/confirm it
9Se alegeun sistemde msurarecorectse iao procedurvalidatişse demonstreaz/ confirmvaliditateaei
Describe measurement system correctly(measurement equation)
9Se descrieînmodcorectsistemulde msurare(modelulmatematicalmsurrii)
State reference to which results are traceable,and demonstrate how
9Se declarreferin a la care sunttrasabilerezultateleşise demonstreazîncefel
Evaluate uncertainty of the results
9Se evalueazincertitudinearezultatelor
Choose suitable CRMs and use them properly
9Se aleg MRC-urile adecvate ş i se folosesccorespunztor
The new global approach
Noua abordare global
World wide initiative by metrology organisations
•Initiativla nivelmondiala organiza iilorde metrologie
Under the system of the Metre Convention
•In cadrul sistemului Conven iei Metrului
Global approach : set up a general system (instead of sector-by-sector !)
•Abordareaglobal: stabilireaunuisistemgeneral (înloculsistemuluisectorial!)
Metrology : putting the highlight onmeasurement basics/skills again !
Metrologia: punedin nouînevidentbazele/tehnicamsurrii!
The Mutual Recognition Arrangement (MRA)
Aranjamentul pentru Recunoastere Reciproc (MRA)
[signed at CIPM, Paris (October 1999)]
[semnatla CIPM, Paris (Oct. 1999)]
Easy to say, difficult to realise
Uşor de spus, greude înfptuit
Mutual recognitionof national measurement standardsand of calibration and measurement certificatesissued by national metrology institutes
Recunoaştereareciproca etaloanelorna ionaleşia certificatelorde etalonareşide msurareelaborate de institutelena ionalede metrologie
Paris, 14 October 1999
Paris, 14 Octombrie1999
Mutual Recognition Arrangement (MRA)JRCB and BIPM key comparison database
Aranjamentulde Recunoa ş tere Reciproc (MRA) Baza de date a JRCB ş i BIPM a comparrilorcheie
At a meeting held in Paris on 14 October 1999, the director of the national metrologyinstitutes (NMIs) of the 33 Member States of the Meter Convention andrepresentatives of two international organisations signed a Mutual Recognition Arrangement (MRA) for national measurement standards and for calibration andmeasurement certificates issued by national metrology institutes.
La întalnireainutla Paris pe14 Octombrie1999, directoriiinstitutelorna ionalede metrologie(INM-uri) ale celor33 de state membreale Conven iei Metrului ş i reprezentan ii celordouorganiza ii interna ionaleau semnat Aranjamentul de Recunoa ş tere Reciproc (MRA) pentruetaloanelena ionaleşicertificatelede etalonareşimsurareelaborate de institutelena ionalede metrologie.
This Mutual Recognition Arrangement is a response to a growing need for an open,transparent and comprehensive scheme to give users reliable quantitative informationon the comparability of national metrology services and to provide the technical basisfor a wider agreement negotiated for international trade, commerce and regulatoryaffairs.
Acest Aranjament de Recunoa ş tere Reciproc este un rspunsla cerin a crescand pentruo schemdeschis, transparent i inteligibil ş care sdeautilizatorilor informa ii cantitativeasupracomparabilit ii serviciilormetrologiceşisasigurebazapentruo întelegerenegociatmailargîneconomiainternational, comertşireglementriînafaceri.
Your National Measurement Institutes(and their partners in chemical measurements)
– Institutele Na ionalede Metrologie(şiparteneriilorînmsurrile chimice)
Provide ‘ready-made’ products to disseminatetraceability (e.g. a value carried by a CRM or by areference measurement)
:Asigurproduse‘gatafcute’ pentrudiseminareatrasabilit ii (ex. o valoaretransmisde un MRC saude o msurarede referin )
Form organised network (e.g. www.euromet.org)(can be contacted for information)
:Formeazre eleorganizate(ex. www.euromet.org)(ce pot furnizainforma ii)
Transparency: they need to document and demonstratemeasurement capability
:Transparent: trebuiesdocumentezeşisdemonstrezecapabilitateade msurare
The challenge : INTEGRATION
Obiectivul: INTEGRARE
QUALITY ASSURANCE
ASIGURAREA CALITATII
Validation ofmeasurementprocedures
Validarea Procedurilorde Msurare
What is validation of a measurement procedure ?
•Ce înseamnvalidarea unei proceduri de msurare?
Why procedure validation ?
•De ce estenecesar?
How to perform validation ?
•Cum se realizeaz?
SOP validation
-GLP utilizeaz“procedurde operare standard ”, SOP � validarea SOP
What is validation ?
Ce este validarea ?
Validation is the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled
Validarea este confirmarea,prin examinareşifurnizarede dovezi obiective, csuntîndepliniteanumitecerin e necesarepentrua folosiprocedurade msurareîntr-un scop bine definit ş i specificat
Validation ofmeasurement procedure
Validarea procedurii de msurare
Process of establishing- performance characterisation- scope & limitation of a measurement procedure- identification of the influenceswhich may change the characteristics and to what extent. - Which analyte can it determine, in which matrices, in the presenceof which interference?
Proces de stabilirea:-caracteristicilorde performan -scopuluişilimitelorunei proceduri de msurare-factorilorde influen care pot schimba caracteristicile, şiînce msur.
- Within these conditions (to be defined) what uncertainty can beachieved?
In aceste condi ii (definite), ce incertitudine se poateob ine?
The process of verifying that a procedure is fit for purpose(i.e. for solving a particular analytical problem)
Procesul de verificare co procedureste potrivitscopului (de ex. pentru rezolvarea unei probleme analitice particulare)
Intended use
Definirea Scopului
-compliance with regulations
- încadrarea în reglement ri
-maintain quality and process control
-men inereacalit ii şicontrolulprocesului
-make regulatory decisions
-emitereadeciziilorde reglementare
-support research
-sus inereacercetrii
Why do we need it ?
De ce avem nevoie de validare?
Laboratories should demonstrate they operate within qualitysystem, are technically competent and are able to generatetechnically valid results
Laboratoareletrebuiesdemonstrezefaptulc, opereazîncadrulunuisistemal calit ii, suntcompetentedin punctde vederetehnicşisuntînmsursob inrezultatevalide
Three milestones of ISO/IEC 17025: procedure validation traceability of results uncertainty of results
Treiobiectiveale ISO/IEC 17025:
Validation is essential EVEN IF you are not going for accreditation
Validarea este esen ial CHIAR SI DACAnu sunte i pe calea acreditrii
Why validation ?
De ce validarea ?
•Provides information on procedure performance characteristics•Increases confidence:
•Oferinforma ii asupra caracteristicilor de performan
–for users of the procedure (analyst)
–Utilizatorilor procedurii (analişti)
–for users of measurement results (customer) better understanding validation is a study of the procedure,NOT of the analyst or of the laboratory performance !
–Utilizatorilor rezultatelor msurrii(beneficiari) mai bunîntelegere
Full Validation:where all relevant parameters of the procedure areinvestigated
Validarea total:cândsunt investiga i to iprocedurii
Degree of Validation:where only some of the performance parameters areinvestigated
Gradul de validare:cândsunt investiga i doar anumi iparametrii de performan
Confirmation:used in relation to (already validated) standardisedprocedures.
Confirmare:utilizatînraport cu proceduri standardizate (deja validate).
No need for additional validation, just a“confirmation” in your lab.
Nu este necesaro validare suplimentar, ci doar o “confirmare” înlaboratorul dvs.
Which procedures should be validated?
� dezvoltate în laborator (in-house)
non-standard in-house developed standard ones used outside their intended scope modified standard
�celestandardizatecare se utilizeazînaltescopuridecatcelepentrucare au fostelaborate
(First) No, confirmation needed
�(Ini ial) Nu, estenecesarconfirmarea
(Then) Yes, within the specified conditions
�(Ulterior) Da, încondi ii specificate
When is a procedure validation needed?
Cand este necesar validarea procedurii?
Sampling & Sample Treatment • validate whole procedure(from sample preparation to measured signal)
• ş i tratare prob valida i întreagaprocedur(de la pregtireaprobeipanla semnalulmsurat)
Instrumentcalib & measur Data treat
Depune efort acolo unde este necesar!
Put the effort where it is needed
Prelucrare date
Decide which characteristics are most relevant for your validation(spend effort accordingly!!)
Decide care dintre caracteristici sunt cele mai relevante pentruvalidarea urmrit (depune efortul corespunztor!!!)
- cholesterol in serum,LOD not important (NO),uncertainty is important (YES)
-colesterol în ser, LOD ne-important incertitudineaeste important
(e.g. better uncertainty of the results USA saves 100 M$/year)
(de ex. incertitudinemaibuna rezultatelor�USA economiseşte100 M$/year)
- survey of environmental contamination [to find hot spots]:range and linearity YES,LOD and size of uncertainty NO
- supravegherea contamin rii mediului [pentru aflarea zonelor periculoase]: domeniu ş i liniaritate DA, LOD ş i incertitudinea NU
- doping control (against limit):LOD is critical,uncertainty is extremely important;range, linearity is not important
-doping(fa delimite): LOD este critic, incertitudineaesteextremde important; domeniul, liniaritateasuntmaipu in importante
… recommended by ISO/IEC 17025 evaluation of uncertainty = systematic assessment of the quantities influencing the result measurement of CRM participation in interlaboratory comparison comparison of results achieved with other procedures
…recomandatde ISO/IEC 17025